FDA INSPECTIONS LAG IN OVERSEAS DRUG FACTORIES

February 29, 2008

Foreign factories that make products destined for American medicine cabinets are inspected far less frequently than U.S. facilities by the Food and Drug Administration (FDA), says the Washington Times.

Consider:

On average, foreign medical factories that plan to bring products to the United States are inspected at a rate of once every 13 years, according to 2002 to 2007 figures in a U.S. Government Accountability Office (GAO) report.

American facilities that produce medical products or drugs are required to be inspected every two years per the Federal Food, Drug and Cosmetic Act.

There is no similar requirement on the frequency of foreign inspections.

The disparity is even greater when looking at individual countries:

The rapidly growing number of Chinese factories sending prescription drugs and medical products to the United States are inspected at a rate of about 2 percent annually.

That means it would take nearly 50 years to inspect all the Chinese facilities if FDA continues at that rate.

Facilities in Switzerland, Ireland and Italy are inspected about once every seven years.

This disparity between foreign and domestic inspections -- particularly in China -- has been highlighted by four deaths and hundreds of allergic reactions related to the blood thinner heparin, which Baxter Healthcare Corp. made in part with ingredients produced in China. The facility was mistakenly missed by FDA inspectors who confused its name with that of another facility already inspected. The source of the problem hasn't yet been determined.